Position Overview:

As a Quality Assurance Engineer you will be responsible for FDA regulatory compliance activities (CAPA administration, Product Complaints, Failure Investigations, Quality Audits, Change Control administration), Supplier Quality, Process Improvement Initiatives, Process and Software Validations. You will participate in various quality system activities as the quality assurance representative, providing guidance on US and international regulatory requirements, as well as the development and maintenance of documents to demonstrate compliance to regulatory requirements.

Principal Duties and Responsibilities (Essential Functions):

To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Triage reported issues related to product complaints, CAPA, and nonconforming material to prioritize required next steps
• Conduct and document investigations to determine root cause of various reported issues (product complaints, CAPA, nonconforming material)
• Responsible for managing the company’s approved suppliers with regards to specific quality requirements
• Applies statistical methods for analyzing data to evaluate the current trends with product and quality system performance.
• Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
• Develops new approaches to solve problems identified during quality assurance activities.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Prepares reports to communicate involvement and results of quality assurance activities.
• Prepares and presents technical and program information to team members and management.
• Directs technical and administrative workers engaged in quality assurance activities.
• Maintains a working knowledge of government and industry quality assurance codes and standards.

Qualifications & Skills:

Minimum Requirements

• 1-3 years experience working with FDA regulated medical devices (Class II minimum)
•  Experience developing SOPs, work instructions and other supporting documents to address domestic and international regulatory requirements.
• Demonstrated working knowledge and a history of successfully implementing quality system elements, including, but not limited to: CAPAs, product complaints, design controls, quality system audits, document change controls, employee training, process and software validation.
• Ability to exercise independent judgement within defined procedures and practices to determine appropriate action.
• Ability to provide guidance and training to company peers
• Ability to travel domestically (~10%) to conduct periodic supplier audits
• Bachelor’s degree in science, engineering, or technical field
• Working knowledge of FDA medical device regulations, guidance documents, international standards (ISO 13485, 14971, 17025)

Desired Skills

• Ability to manage multiple projects simultaneously
• Excellent written and verbal communication skills
• Fluent in English (speaking, reading and writing)
• Excellent organizational skills
• MS Office Suite (Word, Excel, Project, Access, PowerPoint, Visio)
• Statistical S/W (MiniTab, JMP or equivalent)
• ASQ CQE, CQM, or CQA desired
• Six Sigma Green or Black Belt desired

Great Benefits!

• Benefit Eligibility is immediate, enroll on day one of employment.
• Robust 401k plan with 3% employer contribution, no minimum employee contribution required.
• 9 Paid Holidays and Paid Vacation time
• Health / Dental / Vision Insurance
• Short / Long-Term Disability Insurance
• Relocation assistance
• Professional development assistance
• Tuition reimbursement, and more!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.